Adult Dosing

Allergy/Common cold

• 2 tabs PO q6 hrs PRN
• Max: 8 tabs/day

Pediatric Dosing

Allergy/Common cold

• Children >12 yrs
• 2 tabs PO q6 hrs PRN
• Max: 8 tabs/day

• Treatment of rhinitis, itching and watery eyes, sinus congestion, sneezing, and pain or fever associated with allergies or the common cold

• Hypersensitivity to any of the ingredients of the drug
• Concomitant use with MAO inhibitors or within 14 days of stopping MAOI therapy

• N/A

Renal Dose Adjustment

• Renal impairment: Use with caution; dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Use with caution; dose adjustments not defined

See Supplemental Patient Information

• Death may occur from the misuse of this drug in very young children
• Overdose of this product may cause severe liver damage or death, which may occur on exceeding recommended dosages, concomitant use with other drugs containing acetaminophen, or on consuming 3 or more alcoholic drinks every day while receiving therapy. Avoid concomitant use with any other drugs containing acetaminophen
• Avoid therapy in patients allergic to acetaminophen, clemastine, or pseudoephedrine, or to any other antihistamines, decongestants, caffeine pills, diet pills, stimulants, or ADHD medications
• Instruct patients to avoid using any other cough, cold, allergy, or pain medication without consulting their clinician while receiving therapy
• Discontinue therapy and consult a clinician if symptoms last more than 7 days or is accompanied or followed by fever, headache, skin rash, or cough
• Advise patients to avoid driving a motor vehicle or operating machinery, as therapy may cause side effects which may impair thinking
• Avoid becoming overheated or dehydrated during exercise or in hot weather
• Instruct women of childbearing potential to inform their clinician if they are pregnant, breastfeeding, or planning to become pregnant during course of therapy
• Antihistamine produces paradoxical excitation in young children. Use of antihistamines is contraindicated in children <2 yrs

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Cirrhosis of the liver
• Heart disease
• High blood pressure
• Diabetes mellitus
• Glaucoma
• Thyroid disorder
• Enlarged prostate
• Dysuria
• Alcoholism

Supplemental Patient Information

• Instruct patients to strictly adhere to the recommended dose
• Instruct patients to avoid alcoholic beverages during therapy as it can increase the risk of liver damage

Pregnancy Category:NR

Breastfeeding: Acetaminophen component of this combination drug is a good choice for analgesia and fever reduction in nursing mothers. Amounts excreted in milk are much less than doses usually given to infants. Adverse effects in breastfed infants appear to be rare. Small occasional doses of clemastine are acceptable during breastfeeding; larger doses or prolonged use may cause drowsiness and other effects in the infant or reduce milk production, especially in combination with a sympathomimetic or before lactation is well established. Single bedtime doses after the last feeding of the day may be sufficient for most women and will minimize any effects of the drug. Small amounts of pseudoephedrine in breastmilk are unlikely to harm the nursing infant; however, it may cause irritability occasionally. A single dose of pseudoephedrine decreases milk production acutely and repeated use interferes with lactation. Mothers with newborns whose lactation is not well established or mothers who are having difficulties producing sufficient milk should not receive pseudoephedrine. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT). Maternal medication of acetaminophen is usually compatible with breastfeeding; no observable change was seen in the nursing infant while the mother was ingesting the compound. This information is based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776/T6 last accessed 8 Dec, 2011). Manufacturer advises to consult a physician.

• CNS: Confusion, hallucinations, unusual thoughts or behavior, severe dizziness, anxiety, restless feeling, nervousness, seizure, drowsiness, impaired concentration, excitability, insomnia, mild headache
• CV: Arrhythmia, hypertension, chest pain
• GU: Less urination, dark urine
• RESP: Respiratory depression
• EENT: Tinnitus, blurred vision
• GI: Nausea, stomach pain, loss of appetite, clay-colored stools, jaundice, dry mouth, constipation
• DERM: Skin rash, itching, easy bruising, redness under skin
• HYPERSENSITIVITY: Allergic reactions
• MISC: Low fever, unusual weakness, fever, chills, body aches, flu symptoms, tingling

Acetaminophen

• Analgesic, antipyretic; acts primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1 and COX-2, enzymes involved in prostaglandin (PG) synthesis; reduces fever through direct action on hypothalamic heat-regulating center
• Rapid and almost complete absorption
• Metabolized by liver; CYP450: CYP2E1, CYP1A2
• Excreted in urine 85% (5-10% unchanged)
• Half-life: 1.25-3 hrs

Clemastine

• First generation histamine H1 antagonist; competitively antagonizes histamine at H1 receptor sites
• Rapid and complete absorption
• Primarily metabolized by liver; CYP450: Unknown
• Excreted principally in urine
• Half-life: 4-6 hrs

Pseudoephedrine

• Nasal decongestant; acts on alpha-adrenergic receptors in the mucosa of the respiratory tract, producing vasoconstriction and reducing nasal congestion. Also, relaxes bronchial smooth muscle by stimulating beta2-adrenergic receptors
• Metabolized by liver
• Renally excreted (55-75% unchanged)
• Half-life: 9-16 hrs (depends on urine pH)

US Trade Name(s)

• Tavist Allergy/Sinus/Headache

US Availability

Tavist Allergy/Sinus/Headache (acetaminophen/clemastine/pseudoephedrine)

• OTC TABS: 500 mg/0.25 mg/30 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

ENT

Upper Respiratory Combinations

Pulmonary

Upper Respiratory Combinations